BPO vs Hibiclens Soap for Surgical Preparation

NCT04021524 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY00005028
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized trial of benzoyl peroxide soap versus Hibiclens soap for surgical preparation. The objective is to determine whether benzoyl peroxide soap, commonly available in drug stores for over-the-counter acne treatment, is as or more effective than the standard surgical preoperative soap, Hibiclens soap (chlorhexidine gluconate), in reducing loads of Propionibacteria (Propi) on or under the skin of patients prior to shoulder arthroplasty (joint replacement).

Conditions

Propionibacterium Acnes

Outcome Measures

Primary Outcomes (2)

• Number of Patients With a Positive Propionibacteria Swabs on Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate

  Patients were randomly assigned to use either benzoyl peroxide soap or Hibiclens soap (chlorhexidine gluconate) at home the night before and the morning of surgery. On the day of surgery the patients' skin and incisions were swabbed in the operating room prior to shoulder arthroplasty. Specimens were held for 21 days.

  Day of Surgery

• Number of Quadrants on Culture Plate of Propionibacteria Growth - Specimens Taken Day of Surgery After At-Home Washes With Benzoyl Peroxide or Chlorhexidine Gluconate

  This outcome measures the load of Propionibacteria on the skin and incision of participants in the operating room prior to shoulder arthroplasty when patients were randomly assigned to use either benzoyl peroxide soap or Hibiclens soap (chlorhexidine gluconate) at home the night before and the morning of surgery. The Propionibacteria load was quantified based on the growth of bacteria on the agar plate using a quadrant system. Quantitative specimen Propionibacteria values (SpCuVs) were assigned as following: "no growth"= 0, "broth only"= 0.1, "one colony only"= 0.1, and 1 quadrant growth = 1, 2 quadrant growth = 2, 3 quadrant growth = 3, and 4 quadrant growth = 4. Samples were taken on the day of surgery and the cultures were held for 21 days.

  Day of Surgery

Study Arms (2)

Hibiclens Soap

ACTIVE COMPARATOR

Drug: Chlorhexidine Gluconate

BPO Soap

EXPERIMENTAL

Drug: Benzoyl Peroxide 10% Bar

Interventions

Benzoyl Peroxide 10% Bar DRUG

Patients will wash with Benzoyl Peroxide 10% Bar

BPO Soap

Chlorhexidine Gluconate DRUG

Patients will wash with Chlorhexidine Gluconate

Hibiclens Soap

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male subjects
• Subjects scheduled for elective shoulder arthroplasty at the University of Washington Medical Center
• Subjects between ages 18-89

You may not qualify if:

• Subjects who self-report very sensitive skin
• Subjects who are sensitive to benzoyl peroxide
• Subjects who are allergic to chlorhexidine
• Subjects who had recent prior use of antibiotics (or expect to use them prior to surgery)
• Subjects who had recent use of acne treatment
• Subjects who are not fluent in English.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Interventions

Benzoyl Peroxide; Receptors, Catecholamine; chlorhexidine gluconate

Intervention Hierarchy (Ancestors)

Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Receptors, Biogenic Amine; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, G-Protein-Coupled; Receptors, Neurotransmitter

Results Point of Contact

• Title: Dr. Jason E. Hsu
• Organization: University of Washington

jehsu@uw.edu

(206) 543-3690

Study Officials

• Frederick Matsen, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, School of Medicine: Orthopaedics and Sports Medicine

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 16, 2019
• Study Start: September 10, 2018
• Primary Completion: May 31, 2019
• Study Completion: April 16, 2021
• Last Updated: March 15, 2022
• Results First Posted: March 15, 2022

Record last verified: 2021-12

Locations

US (1)